CQV/CV Consultant
Description
The Cleaning Validation Engineer will be directly responsible for writing and executing cleaning validation documents; preparation and execution Cleaning Development, Cleaning Validation, and method validation is a plus. Examples- related to Autoclave Sterilization, SIP and CIP of Filling Vessels and single use system, COP parts washer.
This position will support all cleaning validation activities and strategy with focus on the aseptic filling areas. However, based on client priorities be able to support all GMP manufacturing and QC areas.
Key Responsibilities:
- Develop, review, and maintain comprehensive SOPs / GxP documents related to cleaning validation processes. Including, but not limited to:
- Material Transfer
- Aseptic Behaviors in Filling & Isolators
- Media Fill SOP for Isolators
- Cleaning - Equipment Prep Area, Filling, Formulation
- MFG:
- Gowning: Formulation, Filling, Equipment Prep-
- Filter Flush
- Bulk and water sampling
- Quality / Micro SOPs
- Micro / EM SOPs
- Process Validation / Master Plan
- Cleaning Validation / Master Plan
- Ensure all SOPs / GxP documents are clear, concise, and compliant with regulatory requirements and industry standards.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to gather information and ensure SOP accuracy.
- Conduct periodic reviews of existing SOPs to ensure they remain current and relevant.
- Provide guidance and training to staff on SOP / GxP documents adherence and best practices.
- Perform gap analyses and risk assessments to identify areas for SOP / GxP documents improvement.
- Maintain accurate and organized records of all SOP-related activities and documentation.
- Stay current with industry trends, regulations, and best practices related to SOPs / GxP documents
- Lead initiatives to streamline and optimize SOP / GxP documents processes and documentation practices.
Educational Background:
BS in science or engineering.
Minimum Level of Job-Related Experience required
- Minimum of 5 years pharmaceutical/biotech experience in validation with knowledge.
- Proficient and experience with Kaye validators and temperature data loggers to independently perform temperature mapping studies for autoclave and Vessel SIP
- Proficient and experience with sampling for cleaning validation including independently performing swabbing and taking rinse samples.
- Prior experience preparing and executing equipment qualification documents required.
- SME experience in the following areas is preferred:
- Sterilization Validation (autoclave and vessel SIP)
- Cleaning Validation
Other job-related skills/Background:
- Familiarity with Good Manufacturing Practices
- Must have demonstrated self-direct work habits and strong communication skills.
- Must be a committed team player prepared to work in and embrace a team-based culture.
- Familiarity with regulatory expectations regarding electronic records and electronic signatures.
- Ability to work in a high complex matrix environment.
- Sense of urgency, flexibility and accountability.
- Maintain attention to detail, while completing multiple or repetitive tasks.
- Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
- Maintain a high level of integrity while balancing multiple priorities and responsibilities
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